Pharmaceutical compositions containing octreotide and excipients for oral or rectal administration

Abstract

Polypeptide compositions for inter alia SMS are provided containing a monosaccharide/sugar alcohol and/or a polyoxyalkylene ether having enhanced resorption properties for oral or rectal administration.

What we claim is: 
     
       1. A pharmaceutical composition comprising octreotide and an excipient selected from the group consisting of a) a, monosaccharide, b) a sugar alcohol, c) a monosaccharide and a polyoxyalkylene ether, and d) a sugar alcohol and a polyoxyalkylene ether, and said composition being adapted for gastro-intestinal resorption by oral or rectal administration. 
     
     
       2. A pharmaceutical composition according to claim 1 wherein said excipient c) comprises xylose and polyoxyethylene ether. 
     
     
       3. A pharmaceutical composition according to claim 2 wherein the ratio of xylose to ether is from 2:1 to 1:2. 
     
     
       4. A pharmaceutical composition according to claim 1, wherein the monosaccharide is glucose. 
     
     
       5. A pharmaceutical composition according to claim 1 wherein the monosaccharide is xylose. 
     
     
       6. A pharmaceutical composition according to claim 1 in solid unit dosage form. 
     
     
       7. A pharmaceutical composition according to claim 6 containing from 10 to 500 mg of said monosaccharide or sugar alcohol. 
     
     
       8. A pharmaceutical composition according to claim 6 containing from 5 to 200 mg of said polyoxyalkylene ether. 
     
     
       9. A pharmaceutical composition according to claim 8 wherein the polyoxyalkylene ether is a polyoxyethylene ether. 
     
     
       10. A pharmaceutical composition according to claim 8 wherein the polyoxyalkylene ether is a polyoxyethylene ether of average 24 repeating units. 
     
     
       11. A pharmaceutical composition according to claim 10 wherein the ether is a steroid ether. 
     
     
       12. A pharmaceutical composition according to claim 11 wherein the ether is a polyoxyethylene cholesteryl ether. 
     
     
       13. A pharmaceutical composition according to claim 12 containing 100 mg polyoxyethylene cholesteryl ether, 100 mg xylose and octreotide. 
     
     
       14. A pharmaceutical composition comprising octreotide and an excipient selected from the group consisting of a) a monosaccharide, b) a sugar alcohol, c) a monosaccharide and a polyoxyalkylene ether, and d) a sugar alcohol and a polyoxyalkylene ether, and said composition being adapted for gastro-intestinal resorption by oral or rectal administration and having a relative bioavailability of said octreotide, in blood plasma up to 12 hours after administration, of at least 160% by oral or rectal administration compared with 100% by oral or rectal administration of said octreotide alone. 
     
     
       15. A pharmaceutical composition according to claim 14 containing in a unit dosage form from 50 to 100 mg of said monosaccharide or sugar alcohol. 
     
     
       16. A pharmaceutical composition according to claim 15 wherein said polyoxyalkylene ether is a polyoxyethylene ether. 
     
     
       17. A pharmaceutical composition according to claim 15 wherein said polyoxyalkylene ether is a polyoxyethylene ether of average 24 repeating units. 
     
     
       18. A pharmaceutical composition according to claim 17 wherein said ether is a steroid. 
     
     
       19. A pharmaceutical composition according to claim 18 wherein said ether is a polyoxyethylene cholesteryl ether. 
     
     
       20. A pharmaceutical suppository composition comprising octreotide, a polyoxyalkylene ether excipient, and a suppository base, and said composition being adapted for gastro-intestinal resorption by rectal administration. 
     
     
       21. A pharmaceutical suppository composition according to claim 20 additionally comprising a monosaccharide or sugar alcohol. 
     
     
       22. A pharmaceutical suppository composition according to claim 20 containing in a unit dosage form from 5 to 200 mg of said polyoxyalkylene ether. 
     
     
       23. A pharmaceutical suppository composition according to claim 22 additionally comprising a monosaccharide or sugar alcohol. 
     
     
       24. A pharmaceutical suppository composition according to claim 22 wherein said polyoxyalkylene ether is a polyoxyethylene ether. 
     
     
       25. A pharmaceutical suppository composition according to claim 22 wherein said polyoxyalkylene ether is a polyoxyethylene ether of average 24 repeating units. 
     
     
       26. A pharmaceutical suppository composition according to claim 25 wherein said ether is a steroid ether. 
     
     
       27. A pharmaceutical suppository composition according to claim 26 wherein said ether is a polyoxyethylene cholesteryl ether.